Trial Outcomes & Findings for Phase II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin (MEGO) for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy (NCT NCT03839446)

Last Updated: 2025-02-20

Results Overview

The estimated percentage of patients with Complete Responses (CR / total response-evaluable patients x 100). CR in AML is defined as: 1. Normal values for absolute neutrophil count (\>1000/microL), platelet count (\>100,000/microL), independence from red cell transfusion. 2. Bone marrow biopsy reveals no clusters or collections of blast cells. Extramedullary leukemia (eg, central nervous system or soft tissue involvement) must be absent. 3. Bone marrow aspiration reveals normal maturation of all cellular components (ie, erythrocytic, granulocytic, and megakaryocytic series). No requirement for bone marrow cellularity. 4. \< 5 percent blast cells are present in the bone marrow, and none can have a leukemic phenotype (eg, Auer rods). 5. The absence of a previously detected clonal cytogenetic abnormality (ie, complete cytogenetic remission, CRc) confirms the morphologic diagnosis of CR but is not currently required.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Up to six weeks

Results posted on

2025-02-20

Participant Flow

Participant milestones

Participant milestones
Measure	Mitoxantrone + Etoposide + Gemtuzumab Ozogamicin 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6 mitoxantrone + etoposide + gemtuzumab ozogamicin: 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin (MEGO) for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mitoxantrone + Etoposide + Gemtuzumab Ozogamicin n=16 Participants 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6 mitoxantrone + etoposide + gemtuzumab ozogamicin: 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6.
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
ECOG Status ECOG = 0	1 Participants n=5 Participants
ECOG Status ECOG = 1	15 Participants n=5 Participants
Cytogenetic Status Poor	13 Participants n=5 Participants
Cytogenetic Status Intermediate / Favorable	3 Participants n=5 Participants
Percent bone marrow blasts	50.9 Percent bone marrow blasts n=5 Participants
Percent CD33 expression in leukemia blasts	100 % CD33 expression n=5 Participants

PRIMARY outcome

Timeframe: Up to six weeks

Population: To be evaluable for clinical response, a patient must have received a total of 5 days of mitoxantrone and etoposide, received 1 dose of GO and had a follow-up bone marrow biopsy to evaluate the response to therapy.

Outcome measures

Outcome measures
Measure	Mitoxantrone + Etoposide + Gemtuzumab Ozogamicin n=14 Participants 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6 mitoxantrone + etoposide + gemtuzumab ozogamicin: 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6.
Complete Remission Rate	36 percentage of participants Interval 15.0 to 100.0

SECONDARY outcome

Timeframe: Up to five years

Population: Patients who were evaluable for response to treatment.

The length of time during and after the treatment that a patient lives with Acute Myeloid Leukemia disease that does not progress.

Outcome measures

Outcome measures
Measure	Mitoxantrone + Etoposide + Gemtuzumab Ozogamicin n=16 Participants 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6 mitoxantrone + etoposide + gemtuzumab ozogamicin: 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6.
Progression-free Survival (PFS)	3.27 months Interval 0.92 to 39.43

SECONDARY outcome

Timeframe: Up to five years

Population: All treated patients.

The length of time from the start of treatment that patients are still alive.

Outcome measures

Outcome measures
Measure	Mitoxantrone + Etoposide + Gemtuzumab Ozogamicin n=16 Participants 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6 mitoxantrone + etoposide + gemtuzumab ozogamicin: 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6.
Overall Survival (OS)	17.4 months Interval 7.23 to Upper bound of the 95% CI was not reached due to low number of events.

Adverse Events

Mitoxantrone + Etoposide + Gemtuzumab Ozogamicin

Serious events: 2 serious events

Other events: 16 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Mitoxantrone + Etoposide + Gemtuzumab Ozogamicin n=16 participants at risk 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6 mitoxantrone + etoposide + gemtuzumab ozogamicin: 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6.
Blood and lymphatic system disorders Sepsis	6.2% 1/16 • Number of events 16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations Platelet count decreased	6.2% 1/16 • Number of events 16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Nervous system disorders Nervous system disorders - Other, specifyEpidural, subdural, subarachnoid hematoma	6.2% 1/16 • Number of events 16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.

Other adverse events

Other adverse events
Measure	Mitoxantrone + Etoposide + Gemtuzumab Ozogamicin n=16 participants at risk 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6 mitoxantrone + etoposide + gemtuzumab ozogamicin: 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6.
Blood and lymphatic system disorders Anemia	100.0% 16/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specifyDecreased WBC	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specifyIncreased AST	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specifyIntermittent Decreased Platelets	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specifyLow ACL	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specifyLow ANC	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Blood and lymphatic system disorders Febrile neutropenia	81.2% 13/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Cardiac disorders Cardiac arrest	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Cardiac disorders Cardiac disorders - Other, specifyPVC/SVT	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Cardiac disorders Heart failure	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Cardiac disorders Sinus bradycardia	18.8% 3/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Cardiac disorders Sinus tachycardia	25.0% 4/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Cardiac disorders Ventricular fibrillation	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Eye disorders Dry eye	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Eye disorders Eye disorders - Other, specifyL eye hemorrhage	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Abdominal pain	37.5% 6/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Ascites	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Bloating	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Colitis	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Constipation	18.8% 3/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Diarrhea	56.2% 9/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Dry mouth	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Dyspepsia	18.8% 3/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Dysphagia	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Gastrointestinal disorders - Other, specifyHemorrhoidal Pain	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Gastrointestinal disorders - Other, specifyMelena	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Hemorrhoids	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Ileus	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Mucositis oral	25.0% 4/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Nausea	56.2% 9/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Oral pain	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Gastrointestinal disorders Vomiting	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
General disorders Chills	31.2% 5/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
General disorders Edema limbs	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
General disorders Fatigue	25.0% 4/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
General disorders Fever	43.8% 7/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
General disorders General disorders and administration site conditions - Other, specifydry lips	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
General disorders Generalized edema	18.8% 3/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
General disorders Hypothermia	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
General disorders Localized edema	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
General disorders Malaise	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
General disorders Multi-organ failure	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
General disorders Pain	37.5% 6/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Hepatobiliary disorders Hepatic failure	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Immune system disorders Immune system disorders - Other, specifymyalgia	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Infections and infestations Bacteremia	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Infections and infestations Enterocolitis infectious	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Infections and infestations Infections and infestations - Other, specifyPalmar plantar erythrodysesthesia	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Infections and infestations Lung infection	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Infections and infestations Sepsis	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Infections and infestations Thrush	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Injury, poisoning and procedural complications Fall	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specifyacute kidney injury	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations Activated partial thromboplastin time prolonged	25.0% 4/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations Alanine aminotransferase increased	18.8% 3/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations Alkaline phosphatase increased	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations Aspartate aminotransferase increased	18.8% 3/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations Blood bilirubin increased	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations Blood lactate dehydrogenase increased	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations Creatinine increased	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations Fibrinogen decreased	25.0% 4/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations INR increased	37.5% 6/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations Lymphocyte count decreased	50.0% 8/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations Neutrophil count decreased	25.0% 4/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations Platelet count decreased	75.0% 12/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations Weight gain	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations Weight loss	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Investigations White blood cell decreased	31.2% 5/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Metabolism and nutrition disorders Acidosis	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Metabolism and nutrition disorders Anorexia	37.5% 6/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Metabolism and nutrition disorders Hyperglycemia	37.5% 6/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Metabolism and nutrition disorders Hypermagnesemia	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Metabolism and nutrition disorders Hyperphosphatemia	25.0% 4/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Metabolism and nutrition disorders Hypoalbuminemia	43.8% 7/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Metabolism and nutrition disorders Hypocalcemia	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Metabolism and nutrition disorders Hypokalemia	62.5% 10/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Metabolism and nutrition disorders Hypomagnesemia	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Metabolism and nutrition disorders Hyponatremia	31.2% 5/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Metabolism and nutrition disorders Hypophosphatemia	68.8% 11/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Musculoskeletal and connective tissue disorders Neck pain	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Nervous system disorders Dysgeusia	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Nervous system disorders Encephalopathy	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Nervous system disorders Headache	18.8% 3/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Nervous system disorders Nervous system disorders - Other, specifyBradycardia	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Psychiatric disorders Agitation	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Psychiatric disorders Anxiety	25.0% 4/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Psychiatric disorders Confusion	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Psychiatric disorders Depression	18.8% 3/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Psychiatric disorders Insomnia	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Renal and urinary disorders Acute kidney injury	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Renal and urinary disorders Renal calculi	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Renal and urinary disorders Urinary frequency	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Renal and urinary disorders Urinary urgency	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	18.8% 3/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Respiratory, thoracic and mediastinal disorders Nasal congestion	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifydry nose	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyR Pleural Effusion	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyShortness of Breath	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Respiratory, thoracic and mediastinal disorders Sinus pain	12.5% 2/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Skin and subcutaneous tissue disorders Hyperhidrosis	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Skin and subcutaneous tissue disorders Pruritus	18.8% 3/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Vascular disorders Hypertension	25.0% 4/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Vascular disorders Hypotension	18.8% 3/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Vascular disorders Phlebitis	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.
Vascular disorders Thromboembolic event	6.2% 1/16 • Adverse Events monitored for 4 weeks after discharge and then every 2 weeks until count recovery (defined as ANC ≥ 1000 with or without PLT ≥ 100,000), up to 4 years. All-Cause Mortality monitored up to 4 years.

Additional Information

Barbara M Stadterman, MPH, MSCR, CCRP

UPMC Hillman Cancer Center

Phone: 412-647-5554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place